Text Size

Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy

This study has been completed.
Sponsor:
Information provided by:
Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT00335413
First received: June 7, 2006
Last updated: June 4, 2008
Last verified: June 2008
History of Changes
  Purpose

To evaluate the impact of spironolactone treatment on renal autoregulation in hypertensive type 1 diabetic patients.


Condition Intervention Phase
Hypertension
 Drug: Spironolactone
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Autoregulation of Glomerular Filtration Rate in Patients With Type 1 Diabetes During Spironolactone Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Steno Diabetes Center:

Primary Outcome Measures:
  • Changes in glomerular filtration rate

Secondary Outcome Measures:
  • Changes in blood pressure
  • Changes in albuminuria
  • Changes in fractional albumin clearance

Enrollment: 17
Study Start Date: June 2006
Study Completion Date: April 2007
Detailed Description:

Double-masked, randomized, crossover trial. In random order, patients will be treated with spironolactone 25 mg o.d. and matched placebo for 28 days.

On the last day of treatment, GFR will be determined twice on the same day: first without clonidine and secondly after injection of clonidine (clonidine induces a transient reduction in blood pressure, with no influence on renal plasma flow and GFR), in order to evaluate the effect of antihypertensive treatment with spironolactone on renal autoregulation of GFR.

The study will be preceded by a wash-out period of 1 month for patients receiving antihypertensive medication. Patients will be instructed to measure blood pressure twice daily, three days a week during this period. If, during the washout period, blood pressure exceeds 170/105 mm Hg or persistent edemas develop, treatment with long-acting loop diuretics will be initiated and continued throughout the rest of the study. If blood pressure despite diuretic treatment still exceeds 170 mm Hg systolic and/or 105 mm Hg diastolic, the patient will be excluded from the study and previous/appropriate antihypertensive treatment will be restarted.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • Age between 18 and 70 years
  • Blood pressure ≥ 135 mm Hg systolic and/or ≥ 85 mm Hg diastolic or ongoing antihypertensive treatment
  • Informed consent

Exclusion Criteria:

  • Diabetic nephropathy
  • Other known kidney or renal tract disease
  • Malignant hypertension
  • Blood pressure > 170/105 at baseline or during AHT wash-out period
  • Plasma potassium > 4.7 mmol/l
  • Elevated plasma creatinine (>88 µmol/l for women and >100 µmol/l for men)
  • Symptoms of Ischemic heart disease within 3 months prior to study start
  • Previous cerebrovascular event (apoplexy, TCI)
  • Abuse of medicine or alcohol
  • Pregnancy or breastfeeding
  • Woman of child-bearing age who are not using adequate contraception
  • ASA treatment > 1g/day or regular use of NSAIDs
  • Known allergy to or side-effects of spironolactone
  • Inability to understand patient information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335413

Sponsors and Collaborators
Steno Diabetes Center
Investigators
Principal Investigator: Hans-Henrik Parving, MD,DMSc,Prof Steno Diabetes Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00335413     History of Changes
Other Study ID Numbers: 2006-001453-10, 2612-3144, KA-20060055
Study First Received: June 7, 2006
Last Updated: June 4, 2008
Health Authority: Denmark: Ethics Committee
Denmark: Danish Medicines Agency

Keywords provided by Steno Diabetes Center:
Renal autoregulation
Glomerular filtration rate
Type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypertension
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
 Spironolactone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2012